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Enrolling By Invitation
NCT04957719
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Conditions: Acute Myocardial Infarction
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 25000
Sponsor: Viatris Innovation GmbH
Location: Advanced Cardiovascular, LLC Alexander City Alabama
Summary
This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.
Eligibility Criteria
Main Inclusion Criteria:
* Confirmed diagnosis of symptomatic type 1 acute myocardial infarction (AMI) ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI), no longer than 4 weeks prior to randomization.
* Diagnosis of multivessel coronary artery disease defined as ≥ 50% stenosis on 2 or more coronary artery territories, during a prior cardiac catheterization or cardiac catheterization during the qualifying AMI event and presence of at least 1 of the following risk factors:
* Second prior AMI,
* Diabetes mellitus defined by ongoing glucose lowering treatment,
* Chronic kidney disease defined as estimated glomerular filtration rate less than 60 mL/min/1.73 m2 and either known history of chronic kidney disease or a biomarker of chronic kidney damage,
* Peripheral artery disease at any time prior to randomization,
* Absence of, or unsuccessful coronary revascularization of the qualifying AMI.
* Successful self-administered placebo according to the autoinjector instruction for use training during screening.
Main Exclusion Criteria:
* Increased risk of serious bleeding including any of the following:
* History of intracranial bleed at any time.
* Known uncorrected intracranial vascular abnormality.
* Gastrointestinal bleed requiring hospitalization or transfusion within 1 year prior to screening.
* Already on oral triple antithrombotic therapy (i.e., Dual antiplatelet therapy and oral anticoagulant).
* Known liver impairment significantly affecting the hepatic function.
* Current dialysis.
* Ischemic stroke or transient ischemic attack within 3 months of screening.
* Chronic anemia with hemoglobin \< 10 g/dL.
* Chronic thrombocytopenia with platelet count \< 100,000/mm3.
* Known hypersensitivity to selatogrel, any of its excipients, or drugs of the P2Y12 class.
* Previous exposure to an investigational drug within 3 months prior to randomization.
* Participation in another clinical trial with an investigational product or device within 3 months prior to randomization.
Source: ClinicalTrials.gov (NCT04957719). StuddyBuddy aggregates publicly available trial information.